VOCs in Kidney and Liver Transplants

NCT04514666 | Unknown

• 1 other identifier: 38/2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease. Chronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants. While acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible. Considering the recent application of the breathomic to liver and kidney disease and the difficulty in the early detection of chronic rejection after liver and kidney transplants, the analysis of the exhaled VOCs pattern could help early detection of chronic rejection allowing a prompt medical treatment.

Conditions

Liver Transplant Rejection; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (4)

• Volatile organic compounds in end stage liver disease

  to evaluate the pattern of volatile organic compounds in patients elegible for liver transplant

  30 days

• Volatile organic compounds in end stage kidney disease

  to evaluate the pattern of volatile organic compounds in patients elegible for kidney transplant

  30 days

• Volatile organic compounds after liver transplant

  to evaluate the pattern of volatile organic compounds able to identify the onset of chronic failure/rejection after liver transplants

  1 year

• Volatile organic compounds after liver transplant

  to evaluate the pattern of volatile organic compounds able to identify the onset of chronic failure/rejection after kidney transplants

  1 year

Study Arms (1)

Liver/kidney transplant

EXPERIMENTAL

The breath of patients undergoing liver or kidney transplant will be sampled and analysed

Other: Breath analysis

Interventions

Breath analysis OTHER

The breath of patients undergoing liver or kidney transplant will be sampled and volatile organic compounds will be identified

Liver/kidney transplant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sex
• Patients eligible for liver or kidney transplant
• Written informed consent

You may not qualify if:

• Acute liver failure
• Acute liver and kidney rejection
• HCC
• Re-transplant
• Pregnancy
• IBD
• Any psychiatric disease

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead

Study Sites (1)

Dept of Emergency and Organ transplantation

Bari, 70124, Italy

Location

Study Officials

• Arcangelo Picciariello, MD

  Societa Italiana di Chirurgia ColoRettale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arcangelo Picciariello, MD

CONTACT

+393492185104; arcangelopicciariello@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: October 2, 2021
• Primary Completion: October 2, 2022
• Study Completion: March 2, 2023
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

IT (1)